A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure According to Confirmation by Fiberoptic Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Airway sealing pressure in cmH2O
研究概览
简要总结
Baska mask air way(BM) in comparative study with Proseal laryngeal mask airway (PLMA) regarding performance of Baska mask improves the safety and efficacy of airway management for in patients undergoing general anesthesia by mechanical ventilation confirmation of position by fiber optic view of glottis opening and success of gastric tube insertion , Airway sealing pressure, Leak fraction, insertion time and "overall insertion" success rates, and post-operative complications (airway trauma, hoarseness, sore throat and Dysphagia ).
详细描述
Maintenance of a patent airway is a major responsibility for the anesthesiologists, interruption of gas exchange, even for a few minutes, can result in catastrophic outcomes such as brain damage or death.
Supraglottic airway devices are devices that ventilate patients by delivering anaesthetic gases/oxygen above the level of the vocal cord. Since the development of the laryngeal mask airway, many other supraglottic devices have been introduced in the clinical practice of airway management, trying to offer a simple and effective alternative to endotracheal tube.
However, following experience with such simple cases, clinicians soon become comfortable with more complex cases, such as cases of longer duration, cases with sicker patient reported favorable outcomes in safety profile, risk, ease of insertion, recovery of patients and cost analyses. However, there is an under reporting of complications aris¬ing during ventilation with this device and the risk factors associated with such complications in adult patients. These include Hypoxia, laryngospasm, and difficulty with insertion, suboptimal ventilation, bronchospasm, aspiration, desaturation, hy¬potension and conversion to intubation with ETT. These can be significantly serious and life threatening
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
72 Patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n= 37), in which Baska Mask Airway _ (size 3,4,5) will used for ventilation according of patient body weight.
Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA_ (size 3,4,5) was used for ventilation according of patient body weight
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult ASA I-II patients,
- •Both genders, aged 18-45 years,
- •Body weight between 50 and 90 kg who BMI > 30 kg/m2
- •Non-urgent surgery of planned duration up to 2 hrs
排除标准
- •Patient refusal
- •Patients having known tendency to nausea/vomiting or pharyngeal pathology
- •Morbid obese patients with body mass index >30 kg/m2
- •Patients known to have gastro-esophageal reflux disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery
- •History of difficult intubation, measured the common predictive indices for difficult intubation (BMI, thyromental distance,Mallampati grade, inter-incisor distance, dentition and neck movement ).
结局指标
主要结局
Airway sealing pressure in cmH2O
时间窗: 15 Minutes
The airway sealing pressure is the pressure at which leak starts; in cmH2O at 5 mints post placement, this leak pressure will calculate as the plateau airway pressure reach with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O, and observing of the rise of the ventilator's airway pressure. A ''puffing'' sound was heard near the patient's mouth (release of pressure) indicating the airway seal pressure
次要结局
- Device Complications:(Through study completion)
- Laryngeal view grades recorded by fiberoptic bronchoscopes.(15 Minutes)
研究者
Ahmed Abdalla
Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
Cairo University